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Last Updated: May 24, 2022

LEVITRA Drug Patent Profile


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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Drug patent expirations by year for LEVITRA
Drug Prices for LEVITRA

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Drug Sales Revenue Trends for LEVITRA

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Recent Clinical Trials for LEVITRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tritech Biopharmaceuticals Co., Ltd.Phase 1/Phase 2
A2 Healthcare Taiwan CorporationPhase 1/Phase 2
Azienda USL ModenaPhase 2

See all LEVITRA clinical trials

Paragraph IV (Patent) Challenges for LEVITRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LEVITRA Tablets vardenafil hydrochloride 2.5 mg 021400 1 2009-09-04
LEVITRA Tablets vardenafil hydrochloride 5 mg and 10 mg 021400 1 2009-07-10
LEVITRA Tablets vardenafil hydrochloride 20 mg 021400 1 2009-03-05

US Patents and Regulatory Information for LEVITRA

LEVITRA is protected by two US patents.

Patents protecting LEVITRA

Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEVITRA

International Patents for LEVITRA

See the table below for patents covering LEVITRA around the world.

Country Patent Number Title Estimated Expiration
Taiwan 513431 See Plans and Pricing
Cuba 23473 MEDICAMENTOS QUE CONTIENEN CLORHIDRATO DE VARDENAFILO TRIHIDRATO See Plans and Pricing
Ukraine 85542 ЛЕКАРСТВЕННЫЕ СРЕДСТВА, СОДЕРЖАЩИЕ ГИДРОХЛОРИД ВАРДЕНАФИЛА, И СПОСОБ ИХ ПРИГОТОВЛЕНИЯ;ЛІКАРСЬКІ ЗАСОБИ, ЩО МІСТЯТЬ ТРИГІДРАТ ГІДРОХЛОРИДУ ВАРДЕНАФІЛУ ТА СПОСІБ ЇХ ВИГОТОВЛЕННЯ (METHOD FOR PRODUCING MEDICAMENTS CONTAINING VARDENAFIL HYDROCHLORIDE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 9924433 See Plans and Pricing
Spain 2378358 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004006894 See Plans and Pricing
United Kingdom 0010974 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.